火热炽盛证(实热火毒)诊断标准的建立及诊断阈值的探讨

Consturuction of Diagnostic Criteria and the Diagnostic Thresholds for Intense Fire-heat(Excess Heat and Fire Toxin) Pattern

目的研究火热炽盛证(实热火毒)诊断标准的制定方法,为临床诊断提供依据。方法检索火热炽盛证相关古籍和现代文献数据库,包括《中华医典》及中国知网、万方数据库、维普数据库、中国生物医学文献数据库,对文献初步筛选建立条目池,在此基础上,开展多中心临床现场调查,完善补充修订相关条目。建立专家咨询问卷,通过两轮德尔菲法专家调查,筛选出重要条目和关键条目,对其结果进行专家共识论证,确定火热炽盛证的核心诊断条目,通过层次分析法定权重。采用诊断试验方式,初步探索诊断阈值。结果纳入医案340个、现代文献574篇,获取症状及舌脉7388个,经过初步统计分析筛选出44个症状、8个舌象和8个脉象建立条目池,经多中心临床现场调查补充修订保留相关条目61个。第一轮德尔菲法专家调查保留重要条目38个,第二轮保留关键条目21个,专家共识论证确定核心条目17个。按条目权重等级量化保留条目,形成诊断标准,并纳入287例患者进行诊断试验,通过绘制ROC曲线、计算Youden指数,发现Youden指数最大时,临界值为3.5~5.5分,故初步认为3.5~5.5分是较为合适的诊断区间。结论通过定性和定量研究方法互补、文献与临床结合研制了《火热炽盛证(实热火毒)诊断标准》,可为相关临床试验提供参考。

ObjectiveTo develop the diagnostic criteria of intense fire-heat(excess heat and fire toxin)pattern,thereby providing the basis for clinical diagnosis.Methods Encyclopedia of Traditional Chinese Medicineandelectronic databases including CNKI,Wanfang,VIP and Sino Med were searched for ancient and modern literatureabout intense fire-heat pattern.An item pool was constructed after preliminary screening of the literature,and were re-vised and improved through multi-center investigation.The Expert Consultation Questionnaire was established,andtwo-round Delphi survey was conducted to screen the important and key items.The final diagnostic items of intensefire-heat pattern was determined through expert consensus,and the weight of each item was defined by analytic hierar-chy process.The diagnostic threshold was preliminarily estimated by diagnostic test.ResultsA total of 340 medicalcases and 574 modern papers were obtained,involving 7388 symptoms,tongue and pulse manifestations.Preliminarily,44 symptoms,eight tongue and eight pulse manifestations were selected to construct the item pool,and 61 items wereretained after multi-center investigation.The first round of Delphi survey produced 38 important items,which were re-duced to 21 items after the second round of delphi survey,and 17 items were determined through expert consensus fi-nally.After the weight was calculated,the diagnostic criteria was established.In addition,a diagnostic test of 287 pa-tients was conducted;the ROC curve was drawn and the Youden index was calculated.When Youden index reachedits maximum,the cut-off value was found to be 3.5-5.5 points,so it was preliminarily considered that 3.5 to 5.5 points was an appropriate diagnostic range.ConclusionThe diagnostic criteria for intense fire-heat(excess heatand fire toxin)pattern was developed by combining qualitative and quantitative methods as well as integrating litera-ture review with clinical investigation,thereby providing references for future related clinical trials.